Bot Detector
Download FREE Sample Issue or Article
Subscribe Today
A subscription to IJPC includes a print copy delivered by postal mail and on-line access to electronic PDF copies of your subscribed issues.

Study of Microbiological Safety of 25 Oncology Drugs After Multiple Uses in Aseptic Conditions

Author(s):  Roy Julie, Brault Julie, Joran Pierre, Metrop Raphael, Hildgen Patrice

Issue:  Sep/Oct 2011 - Volume 15, Number 5
View All Articles in Issue

Abstract:  The purpose of this study was to determine the microbiological safety of 25 widely used antineoplastic drugs in order to establish if it is possible to safely use them, after opening, past the 24-hour period that most manufacturers suggest. This is one of the first microbiological studies undertaken for these 25 drugs. The studied antineoplastics were kept following their respective physicochemical stability conservation conditions, which are already well documented and known. All manipulations were performed in the cleanroom of a hospital oncology pharmacy, following aseptic procedures. To reveal potential contaminations (bacterial or mycological) after being opened, the drugs were tested many times and inoculated on many different types of media: TSB Broth (or TSA Agar for colored drugs), Blood Agar Base, and Sabouraud Agar. The tests were performed on the day of opening (Day 0), then again once or twice up to 14 days (on Days 4, 7, or 14) based upon known physicochemical stability. Positive and negative controls were also performed for each type of culture in order to validate the method. No bacterial growth was encountered except for two Blood Agar Bases, where one colony grew. More growth was encountered for the mycological medias (13.9%), but it was considered random since Sabouraud Agar negative controls were 10% contaminated. Twenty-two of the studied drugs were considered microbiologically stable for their studied conditions of conservation (4, 7, or 14 days). The remaining three studied drugs did not conclusively show their microbiological stability. The results suggest that 22 antineoplastic drugs could be kept longer after opening without compromising patient safety. In literature, data exists on the physicochemical stability for these drugs. Generally, pharmaceutical companies recommend that the majority of these drugs shouldn’t be used after an 8-hour period. Therefore, the results of this study can allow for a significant savings in terms of hospital budget by extending the length of usage. However, caution should be exercised when examining these results because the architecture of the cleanrooms cannot be reproduced and because it can have significant impact on the results and safety. Therefore, an internal validation process should be undertaken for each of the pharmacy settings prior to generalizing these results.

Related Keywords: Julie Roy, PhD, Julie Brault, Pierre Joram, Raphael Metrop, Patrice Hildgen, DPharm, PhD, antineoplastic agents, anticancer agents, cancer chemotherapy, microbial contamination, stability, bacterial contamination, fungal contamination


Printer-Friendly Version

Download in electronic PDF format for $55

Related Articles from IJPC
Title (Click for Abstract / Details) Author Issue Page View/Buy
Study of Microbiological Safety of 25 Oncology Drugs After Multiple Uses in Aseptic Conditions Roy Julie, Brault Julie, Joran Pierre, Metrop Raphael, Hildgen Patrice Sep/Oct 2011 428-434 Buy
Wetting and/or Solubilizing Agents, Featured Excipient: Allen Loyd V Jr Jul/Aug 2001 310-312 Buy
Room Temperature Stability of Injectable Succinylcholine Dichloride Roy Julie J, Boismenu Daniel, Mamer Orval A, Nguyen Bao T, Forest Jean-Marc, Hildgen Patrice Jan/Feb 2008 83-85 Buy
Basics of Compounding for the Treatment of Warts Allen Loyd V Jr Mar/Apr 2004 126-129 Buy
Antineoplastic Drug Contamination on the Outside of Prepared Infusion Bags Breukels Oscar, van der Gronde Toon, Simons-Sanders Kathleen, Crul Mirjam Jul/Aug 2018 345-349 Buy
Basics of Sterile Compounding: Contamination Control Akers Michael J May/Jun 2015 232-238 Buy
The Value of Near Infrared Spectroscopy in a Small Hospital Compounding Unit to Control the Risks Associated with Raw Materials Storme-Paris Isabelle, Storme Thomas, Thauvin Maxime, Brion Francoise, Chaminade Pierre, Rieutord Andre Jan/Feb 2009 81-86 Buy
Compounding for the Effects of Weapons of Mass Destruction Sammarco Domenic A Jan/Feb 2003 10-15 View Sample
Basics of Compounding for Hazardous Drugs, Part 2: Regulation and Sources of Contamination Allen Loyd V Jr Nov/Dec 2006 446-448 Buy
Establishing Benchmark Rates of Microbial and Bacterial Endotoxin Contamination for Radiopharmaceuticals Compounded in Commerical Nuclear Pharmacy Settings Weatherman Kara D, Augustine Samuel, Christoff Jeffrey, Galbraith Wendy Mar/Apr 2013 168-174 Buy